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Tuesday, June 15, 2021
Neurological and other Adverse events in Clinical Trials.
Links to FDA documents:
https://www.fda.gov/media/144416/download
https://www.fda.gov/media/144673/download
https://www.fda.gov/media/146338/download
Links to EMA documents:
https://www.ema.europa.eu/en/documents/assessment-report/vaxzevria-previously-covid-19-vaccine-astrazeneca-epar-public-assessment-report_en.pdf
https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf
https://www.ema.europa.eu/en/documents/assessment-report/covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf
https://www.ema.europa.eu/en/documents/assessment-report/covid-19-vaccine-janssen-epar-public-assessment-report_en.pdf
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Tuesday, June 15, 2021Each of the available vaccines had neurological adverse events in clinical trial.
Pfizer showed 1158 cases of"Nervous System Disorders", 6.2% of trial participants. Pfizer and Moderna had cases of Bells Palsy in the clinical trials and have since had post-marketing reports of the same.
Moderna had 1215 “medically-attended Adverse Events” with 91 participants being discontinued from the trial due to the AE. 23.9% of the trial participants reported an “unsolicited AE”
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Moderna had 651 reports of nervous system disorders.
Johnson and Johnson had a case of Gillan Barre Syndrome in the vaccine arm, 6 reports of Tinnitus, with none in placebo arm.
Reports of bells palsy and other facial paralysis as well as autonomic disfunction, myo and peri-carditis and urticaria were also noted in the vaccine arm.
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Tuesday, June 15, 2021AstraZeneca. Data reported to the European Medicines Agency shows Serious Neurological adverse events reported during clinical trials. 0.6% of participants were discontinued from the study due to adverse events. Cases of Transverse Myelitis, Multiple Sclerosis, Acute Demyelinating Encephalomyelitis (ADEM), Chronic Inflammatory Demyelinating Polyradiculopathy and Peripheral sensory neuropathy were also reported. Many other Neurological System Disorders were also reported.
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The neurological events prompted the EMA to include a note about special concerns to watch for as the vaccine was rolled out.
Each of the vaccines showed adverse reactions in the clinical trials, reactions that are now being seen in the general population as the vaccine roll-out continues.
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